BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RING PROFILE 3D 28MM

    MDR report key: 6545569 · Received May 4, 2017

    Report

    Report Number
    2025587-2017-00745
    Event Type
    Injury
    Date Received
    May 4, 2017
    Date of Event
    April 6, 2017
    Report Date
    May 18, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    UDI-DI
    00613994759245
    PMA / PMN Number
    K073324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT SPECIMEN HAS NOT BEEN RETURNED FOR DEVICE ANALYSIS. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCLUSION: SURGEONS OFTEN ATTEMPT TO REPAIR MITRAL VALVES IN LIEU OF REPLACING THEM DUE TO IMPROVED LONG TERM CLINICAL OUTCOMES. THERE ARE TIMES WHEN A VALVE REPAIR IS ATTEMPTED USING AN ANNULOPLASTY DEVICE AND SUBSEQUENT POST REPAIR EVALUATION DEMONSTRATES AN INADEQUATE RESULTS. THIS IS OFTEN DUE TO SUBOPTIMAL ANATOMY, SURGICAL TECHNIQUE, OR INAPPROPRIATE SIZING, AND NOT A MALFUNCTION OF THE DEVICE (1). THERE IS NO INDICATION THAT THE EVENT WAS DUE TO THE MANUFACTURE OF THE DEVICE. THIS EVENT APPEARS TO BE RELATED TO SIZING. MICK ET AL, ANN CARDIOTHORAC SURG 2015; 4(3):230-237. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING IMPLANT OF THIS 28 MM ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 26 MM ANNULOPLASTY RING DUE TO PERSISTENT SEVERE REGURGITATION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327203 RING PROFILE 3D 28MM RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 680R 00613994759245

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention